Vaxart's Oral COVID-19 Vaccine Shows Positive 12-Month Safety in Phase 2b Sentinel Cohort

summarizeSummary

Vaxart reported positive 12-month safety data from the sentinel cohort of its Phase 2b oral COVID-19 vaccine trial, with no serious adverse events, supporting continued development.

check_boxKey Events · Product Development and Regulatory · VXRT

• Positive Phase 2b Safety Data

  The oral pill COVID-19 vaccine candidate showed no vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher adverse events over 12 months in the 400-participant sentinel safety cohort.

• Favorable Adverse Event Profile

  Common adverse events for the oral vaccine were generally less severe and frequent than those reported for the mRNA vaccine comparator, particularly regarding injection site reactions.

• Full Efficacy Data Expected in 2027

  This sentinel cohort was not powered for efficacy. Topline data from the complete 5,400-participant study, including efficacy, is anticipated in 2027.

• BARDA Funding Continues

  The vaccine development is supported by a Project NextGen award from BARDA, valued at up to $344.8 million, which this positive safety data helps to underpin.

auto_awesomeAnalysis · VXRT · Life Sciences

Vaxart announced encouraging 12-month safety data from the initial 400-participant sentinel cohort of its Phase 2b oral COVID-19 vaccine trial. The absence of vaccine-related serious adverse events or sustained severe adverse events is a critical positive step for the program, especially as the company continues to develop its oral vaccine platform with significant BARDA funding. While this data does not include efficacy, it de-risks the safety profile ahead of the full study readout in 2027.